Impact of Reconstruction Method (ASIR, FBP) Used in CT on Bone SPECT/CT Image Quality

NCT ID: NCT01800084

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-05-28

Brief Summary

The main objective of this study is to demonstrate the non-inferiority of SPECT image quality (as measured by the signal / noise ratio) obtained by ASIR reconstruction of very-low-dose CT acquisitions versus the quality of those obtained by filtered back projection (FBP) of low-dose CT acquisitions.

The lower limit of non-inferiority is set to -1, the average SPECT signal / noise ratio TEMP expected is between 5 and 6.

Detailed Description

The secondary objectives of this study are:

A. Demonstrate the non-inferiority of image quality (as assessed by a Likert scale) obtained by ASIR-reconstruction-SPECT versus FBP-reconstruction (the lower-limit of non-inferiority is set at -0.5); B. Verify the non-inferiority of image quality (as measured by the signal / noise ratio)of CT images obtained by ASIR-reconstruction versus FBP-reconstruction (the lower-limit of non-inferiority is set at -0.2); C. Verify the non-inferiority of image quality (as assessed by the Likert scale) of CT images obtained by ASIR-reconstruction versus FBP-reconstruction (the lower limit of non-inferiority is set at -0.5); D. Check that the irradiation dose received by the patient is lower for the acquisition of images reconstructed with ASIR than for the acquisition of images reconstructed with FBP.

E. Check the concordance of two evaluations of image quality (Likert scale) made by nuclear medicine physicians (blinded to each other).

Conditions

SPECT-CT

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients undergoing SPECT-CT

The patients in this study are scheduled for a SPECT-CT at the Nîmes University Hospital as part of their normal care regimen.

Intervention: Device: Asir Image Acquisition

Group Type: EXPERIMENTAL

Asir Image Acquisition

Intervention Type: DEVICE

In addition to their normal image acquisition, a supplementary image acquisition lasting approximately 20 seconds (i.e. an ASIR image acquisition) will be carried out for each patient.

Interventions

Asir Image Acquisition

In addition to their normal image acquisition, a supplementary image acquisition lasting approximately 20 seconds (i.e. an ASIR image acquisition) will be carried out for each patient.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• The patient must have given his/her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• A SPECT-CT exam is scheduled for the patient
• The patient is able to withstand an extended position with the arms behind the head for 15 minutes (i.e. patient is able to undergo a SPECT-CT exam)

Exclusion Criteria

• The patient is participating in another study
• The patient is in an exclusion period determined by a previous study
• The patient is under judicial protection, or any kind of guardianship
• The patient refuses to sign the consent
• The patient has a contra-indication for a treatment necessary for this study (patient is not able to withstand an extended position with the arms behind the head for 15 minutes)
• It is impossible to correctly inform the patient
• The patient is pregnant, parturient, or breastfeeding
• Emergency situations
• Presence of osteosynthesis material (or any other material that would generate an artifact during SPECT-CT) in the spine
• Patient behaviour hampers image acquisition

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louis Sibille, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Locations

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, France

Countries

France

References

Sibille L, Chambert B, Alonso S, Barrau C, D'Estanque E, Al Tabaa Y, Collombier L, Demattei C, Kotzki PO, Boudousq V. Impact of the Adaptive Statistical Iterative Reconstruction Technique on Radiation Dose and Image Quality in Bone SPECT/CT. J Nucl Med. 2016 Jul;57(7):1091-5. doi: 10.2967/jnumed.115.164772. Epub 2016 Mar 24.

Reference Type: RESULT

PMID: 27013695 (View on PubMed)

Other Identifiers

LOCAL/2012/LS-01

Identifier Type: -

Identifier Source: org_study_id

2013-A00070-45

Identifier Type: OTHER

Identifier Source: secondary_id